MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2019-11-25 for NEEDLE 1/2 CIRCLE TAPER POINT MAYO CATGUT .050X1.535 STERILE 216703 manufactured by Aspen Surgical Products, Caledonia.
| Report Number | 1836161-2019-00096 |
| MDR Report Key | 9370627 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2019-11-25 |
| Date of Report | 2019-10-29 |
| Date of Event | 2019-10-17 |
| Date Mfgr Received | 2019-10-29 |
| Date Added to Maude | 2019-11-25 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. JORDAN HACKERT |
| Manufacturer Street | 6945 SOUTHBELT DR. S.E. |
| Manufacturer City | CALEDONIA MI 49316 |
| Manufacturer Country | US |
| Manufacturer Postal | 49316 |
| Manufacturer Phone | 6165367508 |
| Manufacturer G1 | SAME AS ABOVE |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NEEDLE 1/2 CIRCLE TAPER POINT MAYO CATGUT .050X1.535 STERILE |
| Generic Name | SURGICAL NEEDLE |
| Product Code | GAB |
| Date Received | 2019-11-25 |
| Model Number | 216703 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ASPEN SURGICAL PRODUCTS, CALEDONIA |
| Manufacturer Address | 6945 SOUTHBELT DR. S.E. CALEDONIA MI 49316 US 49316 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2019-11-25 |